MHRA Guidance Seeks to Clarify Baseline Submissions

Baseline
submissions usually are required when converting the format for regulatory
submissions or correcting technical issues for previously supplied documents,
MHRA says in guidance released last week. The agency defines a baseline
submission as the submission of all current valid documents, as well as a
statement that only the format—and not the content—has been changed.

MHRA
recommends that baselines are applied when there are no pending regulatory
activities for the product.